Cleared Traditional

BILI-THERAPY SPOT TYPE

K103828 · Atom Medical Corporation · General Hospital
Mar 2011
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K103828 is an FDA 510(k) clearance for the BILI-THERAPY SPOT TYPE, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Atom Medical Corporation (Bonita Springs, US). The FDA issued a Cleared decision on March 29, 2011, 91 days after receiving the submission on December 28, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K103828 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2010
Decision Date March 29, 2011
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LBI — Unit, Neonatal Phototherapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5700

Similar Devices — LBI Unit, Neonatal Phototherapy

All 70
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
K251308 · Thera B Medical Products · Jan 2026
BiliWrap
K243372 · Gerium Medical, Ltd. · May 2025
Infant Phototherapy Equipment
K210289 · Bistos Co., Ltd. · May 2021
Neonatal Phototherapy System
K200031 · Avalon Biomedical (Shenzhen) Limited · Oct 2020
bili-hut
K190899 · Little Sparrows Technologies, Inc. · Sep 2019
neoBLUE blanket LED Phototherapy System
K182178 · Natus Medical Incorporated · Dec 2018